Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Screw, Fixation, Bone
510(k) Number K023021
Device Name MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
Applicant
Smith & Nephew, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact WILLIAM MCCALLUM
Correspondent
Smith & Nephew, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact WILLIAM MCCALLUM
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/11/2002
Decision Date 10/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-